Search results for " guidelines"
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Stability studies on these buffer concentrates following International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q7 guidelines (6), ex…
Article
Biosimilar Quality Requirements
By Feliza Mirasol
Recent guidelines released by FDA emphasize the agency’s efforts to ease the path toward regulatory approval for biosimilars and marks significant action taken by the agency to h…
Article
Using Multiple Techniques in Biosimilar Analysis
These are typically among those listed in the International Council for Harmonization (ICH) Q6B guidelines (1), although it is also important to note that complex generic APIs generally call for more …
Article
Putting Viral Clearance Capabilities to the Test
Bergmann concurs and notes that while these guidance documents work well for monoclonal antibodies and therapeutic proteins, “use of the guidelines for novel types of products can be challenging” and …
Article
CoAs Help Secure the Supply Chain
CoAs Help Secure the Supply Chain
Certificates of analysis can be used to monitor the reliability of products and their suppliers.
By Susan J. Schniepp, distinguished fellow at…
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Best Practices for Data Integrity
In an audit of electronic data, the same guidelines apply. Prior to cutting over to a paperless manufacturing solution, you need to physically send a wet signature on paper to FDA, stating that you de…
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Drug Quality Key to Innovation and Access
A broad industry group adopted guidelines on using the Electronic Product Code Information Services (EPCIS) for lot-level management and item-level traceability of pharmaceuticals (3). Achieving stand…
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Managing Risk in Raw Material Sourcing
“Our efforts are focused on compliance with the International Council for Harmonization’s (ICH) Q7 (for APIs) and IPEC (for bulk pharmaceutical excipients) guidelines to continuously improve our syste…
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Defining Risk Assessment of Aseptic Processes
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
By Susan J. Schniepp
Q: I work in …
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…